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NCT04015011 · ClinicalTrials.gov registry record · NA
Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes
A NA study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT04015011: Clinical Trial NA study, sponsored by NYU Langone Health.
NCT04015011 is a NA study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04015011, a NA study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Total Knee Replacement (TKR) significantly improves function, pain, and overall quality of life in patients with end-stage arthritis of the knee. However, studies show that obesity increases complications and costs associated with TKR. The American Academy of Orthopaedic Surgeons (AAOS) clinical guidelines recommend that patients with a BMI \> 25kg/m2 lose 5% of their body weight prior to surgery. Consequently, although it is not clear how to patients or providers achieve weight loss in this population, some providers and hospitals decline to perform TKR in patients with obesity. Low Calorie meal replacement diets (LCD) are a feasible way to safely promote short-term weight loss of 8-15% at 3-6 months prior to some elective surgeries. This is a pilot efficacy study to test whether a short-term program using a 3-month LCD leads to weight loss and improved patient reported and functional outcomes. 75 patients eligible for knee replacement surgery and willing to undergo non-operative weight management treatment at NYU Langone Comprehensive Obesity Center. This study will establish feasibility and weight loss outcomes in preparation for a multicenter effectiveness trial.
Primary Outcome
Patients who have had recent knee replacement will be weighed at screening, week 5-7, week 11-13, and 30-120 days post surgery
Interventions
- COMBINATION_PRODUCT LCD Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2021-09-30 |
| Phase | NA |
Why NCT04015011 stopped before completion
NCT04015011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which LCD Intervention is the first listed.
NCT04015011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04015011 about?
NCT04015011 is a clinical study titled "Effects of a Three-Month Low Calorie Diet Weight Loss Intervention on Knee Replacement Outcomes". Total Knee Replacement (TKR) significantly improves function, pain, and overall quality of life in patients with end-stage arthritis of the knee. However, studies show that obesity increases complications and costs associated with TKR. The American Academy of Orthopaedic Surgeons (AAOS) clinical gui...
What is the current status of trial NCT04015011?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2019-07-25. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT04015011?
The interventions under investigation include: LCD Intervention (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04015011?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04015011's enrollment target sits among peer trials
13 1911th of 2000 higher than 88 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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